With major public health outlets in the U.S. and abroad recommending the public’s use of naloxone, it leads one to wonder: what is naloxone, how does it work and if it’s so great — why isn’t it more widely available?
Naloxone, a cousin of morphine, has been around since the 1960’s, when chemists in the United States and Great Britain discovered the use of the compound. It is an ‘antagonist’ of opioid receptors — meaning that it attaches itself to the same receptors in the brain that opioids — like morphine, hydromorphone, and heroin — attach to, and halting their effects.
It saves the lives by reversing the key terminal side effect of opioids, respiratory depression. This is why Nalaxone holds the promise that it does, since anyone with minimal training, can end an overdose, returning a victim to consciousness and ordinary breathing.
While the risks of unclean needles used to administer opiates, unknown adulterants in pills and powders bought by users, and psycho-social problem of addiction remain — at least addicts in the throws of an overdose have a chance to live another day. Even though administering the drug is relatively simple, there is little consensus around how to harness it for a maximum public health benefit.
According to the Substance Abuse and Mental Health Services Association (SAMHSA), all 50 states have Naloxone access in some capacity, but there are three models that it is distributed through: traditional, third party and nonpatient specific.
It can be obtained 50 states through the traditional model, requiring patients see a doctor who writes them a prescription that they fill at a pharmacy.
45 states operate with a third party system, allowing someone that isn’t directly at risk to obtain the prescription for use on a high-risk person that they regularly associate with.
49 states allow some form of nonpatient specific access, whether this means visiting a community training session to obtain the drug, or getting it through a standing order from a prescriber.
There is no unifying federal policy on this issue, but overall, the drug is becoming easier to access. For a more detailed description of how each state handles Naloxone policy, I recommend SAMHSA’s guide.
Intranasal doses are about 35 times as expensive as the intramuscular injection with an MSRP between $110-$120. The MSRP for an autoinjector unit costs roughly $4,500. To accomplish its mission, the company wants to get the drug in as many hands as possible, but doses of this kind allow them to train and deploy less of the drug overall.
With the law as it stands in Minnesota, one can only obtain Nalaxone through physician’s standing order. The Steve Rummler Hope Network has forged ties with physicians in the state and pharmaceutical distributors to provide the drug to its trainees, but orders for the autoinjector mean that nonfinancial resources must be pledged toward getting the drug. Greater demand for these other forms, rather than the standards needle method, means that fewer doses of the medication overall will be available to the public — and fewer lives saved as a result.
FDA Convenes Nalaxone Committees
With the growing awareness of Naloxone’s potential benefits, the policy and public conversations have shifted in the direction of how its benefits might best be realized.
On December 17th and 18th, a joint meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will take place in Washington. These committees will discuss their findings and come to an agreement about what to present in their joint recommendation to the agency and take comment from members of the public.
Topics on the agenda include: how to increase access to the drug, whether it should be coprescribed alongside some, or all, opioid drugs, and whether access should be linked to the amount of opiate prescriptions that doctors are allowed to prescribe each year. Members of the public are encouraged to comment on these issues as well, so that their feedback will be reflected in the agency’s decisions on the matter.
Share your thoughts on Nalaxone with the FDA until Dec. 14th here